Belgian pharmaceutical company UCB is dropping its development of minzasolmin in patients with Parkinson's' disease after the ORCHESTRA study failed to meet its primary and secondary endpoints.
The company has announced that in its ORCHESTRA proof-of-concept study (NCT04658186) of minzasolmin, described as an investigational, oral small molecule, alpha-synuclein misfolding inhibitor, the drug failed to demonstrate superiority over placebo.
The ORCHESTRA study was a large Phase IIa, randomised, placebo-controlled, 18-month study of clinical symptoms of disease progression over 12 to 18 months in participants diagnosed with early-stage Parkinson's disease. More than 450 patients were enrolled in the study worldwide.
Now the company says that it is pivoting efforts over to its other drug, glovadalen (UCB0022), an orally available, brain-penetrant, small molecule, designed to make dopamine more potent with the goal of treating Parkinson’s disease symptoms.
Alistair Henry, chief scientific officer at UCB, said: “Our team is grateful to the patients, families and healthcare professionals involved in the minzasolmin development program.
“By leveraging the latest biological evidence, UCB’s strategy includes investigating mechanisms to inhibit the misfolding and propagation of alpha-synuclein - processes believed to underlie the spread of neurodegeneration.
“Alongside this, we are advancing research into innovative therapies for symptom control, recognizing the diverse needs of each patient throughout their disease trajectory.”
The company added that in its disease biomarker data, there was a preliminary signal that the company is working to analyse, but there has been no evident clinical benefit to the drug observed so far. Following the announcement the company’s stock took a small hit, dropping from €185 per share before the announcement, dropping down to €179 per share, before recovering again at €186.
Earlier this year, Annovis Bio announced that its investigational candidate buntanetap tartrate was successful in a Phase III in a subgroup of patients. Elsewhere in the market, US-based pharmaceutical company AbbVie has reported that its Phase III TEMPO-2 trial of tavapadon has met its primary endpoints.
